Role of Herbal Dentifrices in the Management of Plaque Induced Gingivitis

NCT ID: NCT04830176

Last Updated: 2021-04-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-20

Study Completion Date

2021-03-28

Brief Summary

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The clinical cross over study involves the use of two herbal based dentifirices moringa and miswak and its efficacy in reducing plaque induced gingivitis. The patients selected are provided with details regarding the research format and consent taken.

Detailed Description

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The clinical cross over study involves use of miswak and moringa dentifrices. The patients selected are 30 in no and are selected based on having gingival inflammation due to plaque accumulation. All other cases related to gingival inflammation along with patients with underlying systemic disease are excluded from the study.

At baseline, plaque and gingival scores are recorded, followed by giving one of the dentifrice to the patient for brushing. The patients are asked to brush twice a day and asked to report after 72 hrs, following which another recording of plaque and gingival scores are recorded.

The patients are then asked to use their own tooth paste for a period of 2 weeks as a wash out period and recalled after this 2 week interval.

The patients are then given the second dentifrice and asked to brush for 72 hrs and then asked to report again for a plaque and gingival score evaluation.

Conditions

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Gingiva; Infection Plaque, Dental

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

sample size of 30- First group of 15 subjects recording of plaque and gingival scores were recorded. Patients were given first dentifrice and asked to brush for 72 hours and then asked to report. A washout period of 2 weeks followed. The next round, the subjects were given the second dentifrice and asked to brush for 72 hrs and then after a period of 3days asked to report
Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Caregivers
Both the participant and the care provider were masked. They were unaware of the paste they were using as it was marked alphanumerically

Study Groups

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moringa

First phase of subjects were given dentifrice for brushing

Group Type ACTIVE_COMPARATOR

dentifrice

Intervention Type OTHER

use of dentifrices for brushing

miswak

second phase of subjects were given dentifrice for brushing

Group Type ACTIVE_COMPARATOR

dentifrice

Intervention Type OTHER

use of dentifrices for brushing

Interventions

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dentifrice

use of dentifrices for brushing

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* subjects having only plaque induced gingival inflammation

Exclusion Criteria

* Subjects having gingival inflammation related to underling systemic diseases
* Subjects taking medications
* Gingival inflammation related to other causes
Minimum Eligible Age

20 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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A B Shetty Memorial Institute of Dental Science

OTHER

Sponsor Role collaborator

Ajman University

OTHER

Sponsor Role lead

Responsible Party

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sudhir rama varma

Clinical Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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AB shetty Institute of dental sciences

Mangaluru, , India

Site Status

Countries

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India

Other Identifiers

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D-F-19-03-04

Identifier Type: -

Identifier Source: org_study_id

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